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#147: Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation
Monday June 16, 2025 3:45pm - 4:45pm EDT
146BC
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-545-L04-P; CME 1.00; RN 1.00

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Speaker

Introduction to genAI
Ben Moscovitch, MA, MBA

J&J Experience
Joseph Markmann

BMS Experience
Sandra Krogulski, MA

Novartis Experience
David Yao, PharmD


Speakers
avatar for Paul Bolot

Paul Bolot

Global Regulatory Strategist, Bayer Consumer Care AG, Switzerland
Paul Bolot works in Regulatory Policy & Science at Bayer. Prior to joining Bayer, he worked as consultant in regulatory affairs at PharmaLex. He is a pharmacist (PharmD) by training and has a master's degree in international drug development and registration. He is based in Basel... Read More →
avatar for Sandra Krogulski

Sandra Krogulski

Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Sandy Krogulski is an experienced and solution-oriented individual with over 10 years of submission and regulatory experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of... Read More →
JM

Joseph Markmann

Principal Data Science Lead, Global Regulatory Affairs, Johnson&Johnson, United States
avatar for Ben Moscovitch

Ben Moscovitch

Public Policy, Amazon Web Services, United States
Ben Moscovitch leads Amazon Web Services public policy efforts in the Americas for healthcare, life sciences, education, and other sectors. Ben focuses on legislative and regulatory policy reforms to facilitate responsible AI adoption, enable data interoperability, support innovation... Read More →
DY

David Yao

Associate Director, Regulatory Affairs CMC, Novartis, United States
David Yao is an experienced regulatory CMC project lead at Novartis. He is a pharmacist by training with expertise on global regulatory submissions and registrations in the oncology area. In recent years, David has also been leading digital innovation in regulatory affairs, overseeing... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

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